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Flexion Biosciences, Inc.
Osteoarthritis pain
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Current therapies: either lubricant or have severe adverse effects
•HPA (hypothalamic-pituitary-adrenal) axis suppression and
hyperglycemia (Kenalog)
•Lubricant (Hyaluronic acid): not much therapeutic effect
•Oral administration for knee pain (Voltaren): gastrointestinal (GI) and
cardiovascular adverse effects (AEs); have to use the lowest effective
dose for the shortest duration
•Take up to 7 days to work for arthritis pain (Motrin gel)
•Addictive (Opioids)
Non-steroidal anti-inflammatory
drugs (NSAIDs)-induced small
intestinal damage
Problems of current therapies
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Our product has three folds of advantages
New product will have
•No or minimal HPA axis suppression/hyperglycemia: intra-
articular injection
•Dual (anti-inflammatory and analgesic) action: therapeutics
•Extended release: 3-month/injection
HPA axis suppression may result
in death
Slow-release is safer and long-
action
Dual mechanisms
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The market: > billions
Rheumatoid arthritis market size: $53.1b
(https://www.ihealthcareanalyst.com/global-rheumatoid-arthritis-drugs-market/)
Joint pain market size: >$5b in 2023; topical pain relief market $10.5b in 2023; and post operative
pain market $35.5b in 2022.
(https://www.polarismarketresearch.com/industry-analysis/joint-pain-injections-market)
https://www.precedenceresearch.com/joint-pain-injections-market
US market
•>15 million of 59 million arthritis American
have severe joint pain: $700/unit *15m =
$10.5b
•Hyaluronic acid (Durolane) cost: $372-
2750/injection
•Zilretta cost: $692/unit
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New product expected to be dominant vs competitors
Product Brand Anti-
inflammator
y
Analgesic Duration Adverse
Effects
Our Product Duaxion v v Every 3-6
month
SAFE
Hyaluronic
Acid
Triluron,
Hyalectin
monthly (Lubricant)
Glucocorticoid
s
Kenalog,
Zilretta
v Daily to
every three
month
HPA axis
suppression/H
yperglycemia
NSAIDs Voltaren,
Naproxen
v daily GI, CV AEs
Opioids v Addictive
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IP is patentable with practical de-risked strategies
Intellectual property (IP): ways to cover with patents
•Novel chemical entity (NCE) (patent drafted)
•NCE with PLGA composites
•Production process (NCE and composite)
Strategies to approach
•Intra-articular injection to limit systemic AEs
•Prodrugs of current active drugs to lower the regulatory hurdle and de-risk development path
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Fund to raise and one-year plans
Seeking pre-seed/seed:
$60k: make 3-5 proto compounds
$200k: confirm the dose reduction potential of the proto compounds in vivo
$800k: prepare sustained release form and analyze blood drug concentration for HPA axis
suppression and hyperglycemia in animal model, efficacy and non-GLP tox.
Main tasks
\month 1 2 3 4 5 6 7 8 9 10 11 12
Proto 3
-5 compounds synthesis: $60k
Assay set
-up and evaluation of stability, and biomarker:
$200k
Complete knee and blood PK: $200k
Microparticle prep
, and encapsulation and PK: $200k
$200k
Optimization of ratio, linker: $200k
In vivo efficacy: $200k
Non
-GLP tox: $200k
Project review
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Projected pipeline and markets
Contact: 650 503 4718, flexionbio@gmail.com
Area Program Indication Exploratory Proof of Concept
(POC) Optimiztn IND Clinical Trials
Estimated
Commercializa
tion
Arthritis
($5-20b market) FB-1
(Intra-articular) Osteoarthritis
pain (Patent draft)
($3-10b market) FB-1
(Topical)) Inflammation/
analgesic
FB-1
(Oral) Inflammation/
analgesic
Anemia
($5-20b market)
FB-2
(Targeted
delivery)) Anemia (Patent draft)
Cancer
($8-13b market)
FB-3
(Targeted
delivery) Kidney cancer -
Antibacterial TBD TBD -
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Project questions answered
1: Is the product much better than the existing products?
•The product will be the best osteoarthritis pain therapy: efficacious, safer (with minimal HPA
axis suppression and hyperglycemia, etc.) and long action.
2: Can you find and market the product to the users of the product?
•About 21.2% of all adults, or 53.2m people in US, have arthritis. Market size is >billions.
3: Is the market growing?
•According to multiple sources, CABG at high digit %.
4: Is the product defendable?
•Yes, new NCE. Patent has been drafted.
5: Can you get the team, knowledge and capital to build the product?
•Yes, the path has been paved, but it may require $40-50m to go through clinical phases 1-2a
for IPO.
